The safety and efficacy of Precedex® has been evaluated in two randomized, double-blind, parallel-group, placebo-controlled multicenter clinical trials in 754 patients being treated in a surgical intensive care unit (ICU). All patients were initially intubated and received mechanical ventilation. These trials evaluated the sedative properties of dexmedetomidine by comparing the amount of rescue medication (midazolam in one trial and propofol in the second) required to achieve a specified level of sedation (using the standardized Ramsay sedation scale) between Precedex® and placebo from onset of treatment to extubation or to a total treatment duration of 24 hours. The Ramsay Level of Sedation Scale is displayed in Table 2.

Table 2: Ramsay Level of Sedation Scale

In the first study, 175 patients were randomized to receive placebo and 178 to receive dexmedetomidine by intravenous infusion at a dose of 0.4 mcg/kg/hr (with allowed adjustment between 0.2 and 0.7 mcg/kg/hr) following an initial loading infusion of 1 (one) mcg/kg IV over 10 minutes. The study drug infusion rate was adjusted to maintain a Ramsay sedation score of ≥ 3. Patients were allowed to receive "rescue" midazolam as needed to augment the study drug infusion. In addition, morphine sulfate was administered for pain as needed. The primary outcome measure for this study was the total amount of rescue medication (midazolam) needed to maintain sedation as specified while intubated. Patients randomized to placebo received significantly more midazolam than patients randomized to dexmedetomidine (see Table 3).

A second prospective primary analysis assessed the sedative effects of dexmedetomidine by comparing the percentage of patients who achieved a Ramsay sedation score of ≥ 3 during intubation without the use of additional rescue medication. A significantly greater percentage of patients in the dexmedetomidine group maintained a Ramsay sedation score of ≥ 3 without receiving any midazolam rescue compared to the placebo group (see Table 3).

Table 3: Midazolam use as rescue medication during intubation (ITT) Study One

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